Abstract: A pressure equalizing assembly with a nonporous membrane traversing across an acoustic pathway defined by an opening in a housing. A breathable layer connected to the nonporous membrane may be laterally arranged to the acoustic pathway. An acoustic cavity is defined by the breathable layer and nonporous membrane. The nonporous membrane has a side facing the opening in the housing to prevent fluid or moisture from penetrating into the acoustic cavity. The breathable layer further equalizes pressure in the acoustic cavity by providing a venting layer.

Abstract: Controlled deployable medical devices that are retained inside a body passage and in one particular application to vascular devices used in repairing arterial dilations, e.g., aneurysms. Such devices can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial re-positioning, resulting in precise alignment of the device to an implant target site.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

Abstract: A garment having an inner surface and an outer surface for use with a safety strap, the garment comprising a collar configured to at least partially encircle an upper portion of the garment, a garment port arranged on or adjacent to the collar forming a channel between the inner surface and the outer surface of the garment, the garment port having at least three sides, one of the sides being open to form the channel, a flap coupled to the collar and configured to move between a closed configuration covering the port and allowing passage of the safety strap through the channel between the inner surface and the outer surface of the garment and an open configuration allowing removal of the safety strap through the open side of the port, and a closure device arranged with the flap and configured to maintain the flap in the closed configuration.

Abstract: Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: The present invention provides a stretchable material suitable for use in an inflatable medical device. The stretchable material has at least one reinforcing polymer layer with a top and bottom side forming a porous matrix which is imbibed with a sealing material to infiltrate and substantially seal spaces of the porous matrix and extend beyond the reinforcing polymer layer to form a surface coating.

Abstract: Systems and methods for detecting syringe seal defects are described, including associated syringe stopper designs having seal areas and indicating areas, as well as associated inspection systems and methods for optical imaging and analysis for syringe seal defects in dry and wet syringes.

Abstract: A catheter package and method of use which serve to straighten a curved catheter shaft. The straightening of the catheter shaft may be accomplished by passing the shaft through a pathway that bends the catheter in the opposite direction of the curvature imparted to the catheter shaft. The catheter shaft pathway may incorporate various shaped bumps, ridges, pins or rollers or other features which assist in straightening the shaft.

Abstract: An device including a proximal portion adapted for placement intermediately within a hollow body cavity to capture and divert contents; the proximal portion being expandable from an initial state with an initial diameter, into an expanded state with a diameter greater than the initial diameter for engaging the proximal portion with an inner wall of the hollow body cavity; and a distal portion, connected to the proximal portion, adapted to extend through the abdominal wall or into the intestine to conduct the hollow body cavity contents out of the proximal portion.

Abstract: An implantable containment apparatus for receiving and retaining a plurality of cells for insertion into a patient, such as into a tissue bed, is disclosed. The device includes a chamber having structural spacers therein to maintain an average distance between the first interior surface and the second interior surface of the chamber and to define at least one reservoir space for the placement of cells within the chamber.

Abstract: A length extensible implantable device includes a porous member and a longitudinal constraining member. The longitudinal constraining member can constrain at least a portion, up to the entire length of, the porous member in the longitudinal direction. The length of the longitudinally constrained portion can be expanded by applying force to the porous member. The porous member may be a porous tubular member.

Abstract: The invention relates to medical devices and methods of using them. The devices are prostheses which can be percutaneously deliverable with (or on) an endovascular catheter or via other surgical or other techniques and then expanded. The prostheses are configured to have a lattice resistant to dilation and creep, which is defined by a plurality of openings. The prosthesis may also optionally have a stent disposed proximal to the lattice. In exemplary embodiments, the fluoropolymer is expanded polytetrafluoroethylene. The composite materials exhibit high elongation while substantially retaining the strength properties of the fluoropolymer membrane. In at least one embodiment, the lattice is made of a composite material that includes a least one fluoropolymer membrane including serpentine fibrils and an elastomer. A lattice including a generally tubular member formed of a composite material including a least one fluoropolymer membrane containing serpentine fibrils and an elastomer is also provided.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

Abstract: A medical device for sealing a defect in a body includes a wire frame that includes a plurality of wires that form a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member. The defect-occupying portion is adapted to fill a wide range of potential defect sizes, such that no more than five devices of a range of sizes are required to effectively seal a range of nominal defect sizes of approximately 8 to 35 mm.

Abstract: The invention relates to medical devices and methods of using them. The devices are prostheses which can be percutaneously deliverable with (or on) an endovascular catheter or via other surgical or other techniques and then expanded. The prostheses are configured to have a lattice resistant to dilation and creep, which is defined by a plurality of openings. The prosthesis may also optionally have a stent disposed proximal to the lattice. In exemplary embodiments, the fluoropolymer is expanded polytetrafluoroethylene. The composite materials exhibit high elongation while substantially retaining the strength properties of the fluoropolymer membrane. In at least one embodiment, the lattice is made of a composite material that includes a least one fluoropolymer membrane including serpentine fibrils and an elastomer. A lattice including a generally tubular member formed of a composite material including a least one fluoropolymer membrane containing serpentine fibrils and an elastomer is also provided.

Abstract: Poly(ethylene tetrafluoroethylene) (ETFE) polymers having an average molecular weight of at least 300,000 g/mol and a melt enthalpy of at least 57 J/g are provided. The ETFE polymer may include at least one additional comonomer. The ETFE polymer is used to form a porous tape or membrane that has a node and fibril structure. A porous ETFE tape may be formed by lubricating the ETFE polymer and subjecting the lubricated polymer to pressure at a temperature below the melting point of the ETFE polymer. Optionally, the ETFE tape may be expanded at a temperature below the melting temperature of the ETFE polymer to form an expanded ETFE membrane. Alternatively, the ETFE polymer may subjected to heat and pressure without the addition of a lubricant to form a dense preform. The dense preform may be subsequently slit in a length direction and stretched to form a dense ETFE fiber.

Abstract: An endoluminal device comprises a tubular member and a reinforcement member that is separable from, or together with, a wall of the tubular member, and removable in-situ.

Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: Described embodiments are directed toward centrally-opening leaflet support devices having a frame and one or more support leaflets coupled to the frame forming a hinge where coupled. The described support leaflets have one or more stiffer regions that facilitate the function of a support leaflet to decrease or prevent prolapse of a native valve leaflet. Methods of making and using such valve devices are also described amongst others.